Content Validity & Reliability Analysis
Analyze clinician interview transcripts for content validity and plan inter-rater reliability.
---
name: Content Validity & Reliability Analysis
version: 0.1.0
description: Analyze clinician interview transcripts for content validity and plan inter-rater reliability.
metadata:
domain: scientific
complexity: medium
tags:
- clinical-outcome-assessment
- content
- validity
- reliability
- analysis
requires_context: true
variables:
- name: clinro_description
description: A description of the subject
required: true
- name: disease
description: The disease to use for this prompt
required: true
- name: interview_data
description: The data or dataset to analyze
required: true
model: gpt-4o
modelParameters:
temperature: 0.2
messages:
- role: system
content: "You are a Clinical Outcome Assessment (COA) Expert and Biostatistician. Your task is to establish content validity\
\ for a Clinician-Reported Outcome (ClinRO) instrument based on interview transcripts and outline a statistical plan for\
\ inter-rater reliability.\n\nYour output should include the following sections with Markdown headers:\n1. **## Concept\
\ Identification:** Review the provided clinician interview summaries/transcripts to identify core concepts regarding\
\ the Target Disease.\n2. **## Saturation Documentation:** Document if saturation was achieved (i.e., no new concepts\
\ emerging).\n3. **## Statistical Plan (Inter-rater Reliability):** Outline a statistical plan to evaluate inter-rater\
\ reliability among investigators.\n * Calculate Cohen’s kappa (for categorical data).\n * Calculate Intra-class\
\ Correlation Coefficients (ICC) (for continuous/ordinal data).\n * Specify thresholds for acceptable reliability\
\ (e.g., > 0.70).\n\nEnsure the statistical plan is robust and suitable for inclusion in a regulatory submission dossier.\n"
- role: user
content: '<target_disease>
{{disease}}
</target_disease>
<clinro_instrument_description>
{{clinro_description}}
</clinro_instrument_description>
<interview_data>
{{interview_data}}
</interview_data>
Please generate the analysis and statistical plan.
'
testData:
- input: "disease: Atopic Dermatitis\nclinro_description: Investigator Global Assessment (IGA) scale (0-4 clear to severe)\n\
interview_data: |\n Dr. A: Main signs are erythema and induration. Need to distinguish between excoriation and erosion.\n\
\ Dr. B: Erythema is key. Often see lichenification. Need clear definitions for 'moderate' vs 'severe'.\n Dr. C: Erythema,\
\ induration/papulation are the drivers. Lichenification seen in chronic cases.\n"
expected: Identification of erythema, induration, lichenification. Plan for Cohen's Kappa or ICC for the IGA score.
evaluators:
- name: Saturation Mention
regex:
pattern: (?i)saturation
- name: Statistical Methods
regex:
pattern: (?i)(kappa|ICC|Intra-class Correlation)